AccessGUDID - DEVICE: Halo Systems (05690977368965)

GUDID

Device Identifier (DI) Information

Brand Name: Halo Systems
Version or Model: 522CS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 522CS
Company Name: OSSUR AMERICAS, INC.

Primary DI Number: 05690977368965
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 139280028 *Terms of Use

Device Description: Skull Pin 2-1/4in CT Sterl 6PK

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46664	Cervical spine immobilization head ring rod	An implantable, threaded rod that is a component of a cervical spine immobilization system (commonly known as a Halo vest) designed to secure the head ring to the skull of the patient by penetrating the outer bone of the skull at brow level. Commonly referred to as a pin, it is typically made of metal (e.g., stainless steel), may be ceramic-tipped, or made of non-ferromagnetic materials. It is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYT	FIXATION ACCESSORY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040363	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3f9d9da9-f7fa-425c-8be0-2e651fa4bc44
Public Version Date: September 18, 2023
Public Version Number: 4
DI Record Publish Date: May 16, 2018